Fina, Fabrizio; (2020) Fused deposition modeling (FDM) 3D printing of oral modified release dosage forms. Doctoral thesis (Ph.D), UCL (Univerity College London).

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Abstract

3D printing is an innovative manufacturing technology that is able to produce bespoke objects by precise deposition of materials in successive layers. Already well recognised in the metal, ceramic and plastic manufacturing industries, recently 3D printing has approached the pharmaceutical field aiming to revolutionise the way medicines are produced. Amongst different 3D printing technologies, fused deposition modeling (FDM) is at present the most common, affordable, and widely investigated technique in pharmaceutical research with the potential to be implemented soon in pharmacies (personalised medicines for the patients) and pharmaceutical industries (flexible dosages during early phase clinical trials). The overall objective of this thesis was to fabricate a range of modified release oral medicines by FDM 3D printing (printlets) using pharmaceutical grade excipients and to investigate the limitation of both materials and FDM 3D printing technology. Hot melt extrusion (HME) was employed to produce feedstock filaments suitable for FDM 3D printing. Filaments with pharmaceutical grade excipients were successfully extruded and utilised to print a range of oral printlets such as enteric printlets, prolonged release printlets, and osmotic pump printlets. Enteric printlets based on three different grades of hydroxypropylmethyl cellulose acetate succinate (HPMC-AS), released less than 10% of the drug in the first 2 h, complying with the USP requirement for delayed release formulations (less than 10% drug release in the first 2 h at pH 1.2). Prolonged release printlets, named core-shell printlets, were realised with a slow release core and an insoluble shell. Three shell designs (different number of holes or different hole sizes) and three core infills (25, 50, 100%) were demonstrated to produce a range of zero-order release profiles spanning from 12 h to 48 h. Osmotic pump printlets were manufactured with a swellable core and a semi-permeable membrane. Cellulose acetate was successfully employed to print membranes with different thicknesses ranging from 250 to 50 μm. This thesis showed the potential to fabricate a range of different modified release printlets using pharmaceutical grade excipients with personalised release profiles tailored to the patients.

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